Status and phase
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About
The purpose of this multicenter, Phase II trial is to examine the role of a well-tolerated novel agent, panitumumab, in combination with a modern platinum doublet regimen using carboplatin and pemetrexed, in patients with advanced non-squamous wild type K-ras non-small-cell lung cancer (NSCLC). If this treatment proves to be well tolerated and associated with efficacy, this would provide rationale for further randomized studies.
Enrollment
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Volunteers
Inclusion criteria
Age ≥18 years.
Histologically confirmed non-squamous NSCLC (squamous cell histology is ineligible). Cytologic specimens obtained by brushings, washings or needle aspiration of the defined lesion are acceptable. Sputum cytology alone is not acceptable. Mixed tumors with small cell elements are not eligible.
Newly diagnosed unresectable stage IIIB or stage IV disease. Patients with stage IIIB disease should be ineligible for combined modality therapy (i.e., pleural effusions, pericardial effusions, etc.).
At least one unidimensionally measurable lesion definable by magnetic resonance imaging (MRI) or computed tomography (CT) scan. Measurable disease is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Demonstration of K-ras wild type in archived tumor tissue. Tissue must be available for testing or results from previous K-ras testing must be available at the time of registration.
No prior antineoplastic chemotherapy for metastatic lung cancer. Patients may have received adjuvant treatment for stage I, II or III disease.
For patients who have had previous radiotherapy as definitive therapy for locally advanced NSCLC, recurrence must be outside of the original radiation therapy port. Radiation therapy must have been completed more than four weeks prior to study entry. Previous radiation must have covered < 30% of marrow bearing area.
Full recovery from surgery for patients who have undergone thoracotomy. Patients cannot start protocol treatment until at least three weeks after an operative procedure.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy ≥ 12 weeks.
Normal bone marrow function within 7 days prior to initial treatment as defined by:
Normal hepatic function as defined by:
Normal renal function within 7 days prior to initial treatment as defined by:
Normal metabolic function as follows:
• Magnesium ≥ institutional lower limit of normal (LLN)
The ability to take folic acid, vitamin B12, and dexamethasone according to the protocol.
The ability to interrupt non-steroidal anti-inflammatory drugs (NSAIDs) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed.
Negative serum or urine pregnancy test within 7 days prior to initial study treatment.
Agreement of women of child-bearing potential (WOCBP) and men to use adequate contraception (hormonal or barrier method of birth control; abstinence) to prevent contraception during treatment and for a minimum of 6 months after the last study treatment.
Willingness and ability to comply with study and follow-up procedures.
Ability to understand the nature of this study and give written informed consent.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
70 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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